Changes to the Common Rule

You may have heard that the federal government is updating the regulations governing human subjects research, as outlined in the “Common Rule” (45 CFR Part 46). These changes touch on critical issues such as informed consent, increased protections for participants, and the expansion of exempt categories of research. While these changes are designed to reduce the administrative burden associated with research, they will come with additional responsibilities that will affect both the university administration and our research community.

What is being done to prepare for these changes?

The University of Miami (UM) is committed to excellence in research. In furtherance of this commitment, a committee comprising representatives of the Office of the Vice Provost for Research, Research Compliance and Quality Assurance, Human Subjects Research Office, Office of Research Administration, Office of Privacy & Data Security, Office of Research IT, and Clinical Research Operations & Regulatory Support is working with key stakeholders to identify areas of policy, draft templates, and guidance documents that will need to change to bring our institution into compliance with the new Common Rule stipulations.

The committee’s goal is to serve as a resource to the research community in navigating the impending rule changes. In the upcoming weeks, further notifications and bulletins will be disseminated to explain changes to UM process, policy, and procedure made in response to the Common Rule revisions.

Timing Question

The majority of rule changes are scheduled to take effect on January 19, 2018. While it is possible that this deadline could be delayed, we are assuming no change so that the university will be fully prepared.

HRPP Town Hall Meeting – Dec. 12, 2017

On December 12, 2017, the UM Human Research Protection Program hosted a town hall meeting to announce the forthcoming changes to UM policies and procedures that would be impacted by the revisions to the Common Rule. the slides presented at that town hall are linked below.

Revised Common Rule Slides

IRB Toolkit Revisions

The following draft SOPs, Worksheets, Checklists, Templates or other documents have been modified to ensure compliance with the Revised Common Rule. All documents are subject to change but have been provided to assist researchers in anticipation of the effective date of 1/19/2017.

WORKSHEET: Drugs (HRP-306)
WORKSHEET: Exemption Determination (HRP-312)
WORKSHEET: Criteria for Approval (HRP-314)
WORKSHEET: Additional Federal Agency Criteria (HRP-318)
TEMPLATE INFORMED CONSENT: Biomedical Research (HRP-502)
TEMPLATE INFORMED CONSENT: Social, Behavioral and Educational Research (HRP-502)